Infinity OCT System
K-Number: K253129 · 2025-10-24
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2025-10-24
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Infinity OCT System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K253129. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinity OCT System?
Infinity OCT System is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253129.
When was Infinity OCT System approved by the FDA?
Infinity OCT System received FDA 510(k) clearance on 2025-10-24, under approval number K253129.
What company makes Infinity OCT System?
Infinity OCT System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for Infinity OCT System?
The FDA product code for Infinity OCT System is NKG.
Related Clinical Trials
Other Devices by Medtronic Sofamor Danek USA, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.